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Reverse Engineering of a Pharmaceutical Formulation Using the Morphologi G3-ID

Published 09 October 2014 | By Malvern Panalytical

According to the definition established by the FDA, a generic drug is "a drug product which is comparable to a reference listed drug (RLD) product in dosage form, strength, route of administration, quality, performance characteristics, and intended use". Rigorous rules and regulations pertaining to abbreviated new drug application (ANDA) submissions are complex and the generic drug industry strives to meet these regulations to obtain FDA's approval.

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Reverse Engineering of a Pharmaceutical Formulation Using the Morphologi G3-ID